Senior Q.A. Manager

Job Description

Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research.

Job Spec

Responsible for performing key Quality tasks in respect of Company products. Work in the Quality Group within the Technical Operations Department, which oversee contract manufacturing operations, select supply chain operations and development functions as well as Internal Quality Systems. Reporting directly to the Director of Quality Operations
The position is responsible for monitoring and supporting the day-to-day Quality activities relating to the performance of contract manufacturing organisations and material suppliers to all applicable GXP standards. This position also involves membership of the External Manufacturing Product Teams Specifically, this position is responsible for developing commercial Quality oversight systems for existing products transitioning into the commercial portfolio and those transitioning from the Investigational Medicinal Product space to Commercial Medicinal Product space. This responsibility extends also to API manufacture.
Responsible for, but not limited to:

Primary Quality representation on an External Manufacturing Product Team(s) and the provision of quality updates, guidance and decisions in relation to the teams product

Leading and monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, validation protocols, change controls and leading product related investigations

Ensuring compliance of all respective contract manufacturers to both internal requirements and country specific regulations

Collaboration with all contract manufacturers, packagers and testing laboratories to resolve any quality issues.

Contributing as required to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, packagers and laboratories, as required.

Highlighting any risks associated with maintaining supply of commercial drug products to the External Manufacturing Product Team(s) and Quality Leadership.

Conducting vendor audits and vendor site visits as required

Assisting in internal audits and regulatory agency inspections

Processing out-of-specification (OOS) reports and provision to QC for review

Reviewing product stability data and provision of data to QC for review and trending

Communicate, where appropriate, with the Corporate Compliance group, on areas of common interest.

Communicate, where appropriate, with all corporate personnel and contribute to the development of global systems and procedures, as required.

Contribute to the design and implementation of best practice quality improvement programmes and company expansion programmes.

Contribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents.

Contribute, as required, to the development of new drugs, which will deliver a robust product pipeline without significant delays in the regulatory approval process.

Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines

Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.

Person Spec

Bachelor's degree in chemistry, pharmacy or other related life science discipline

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The RFT Group, are an Irish recruitment agency specialising exclusively in the recruitment of scientists, engineers and executives for the pharmaceutical, biopharmaceutical and medical device sectors across Ireland, Europe and Rest of World.